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United States · US · US:55150-459_1e7bd8be-a282-4c66-8e1f-bb3ef78c327a

CARBOPROST TROMETHAMINE

Orange BookUNIISPLATC G02AD

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeG02AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515045910
    10 VIAL, SINGLE-DOSE in 1 CARTON (55150-459-10) / 1 mL in 1 VIAL, SINGLE-DOSE (55150-459-01)

Annotations

UNII (FDA Substance ID)
U4526F86FJ
CARBOPROST TROMETHAMINE
RxCUI 20259
Orange Book
A216939
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U4526F86FJ",
    "rxcui": "20259",
    "inchikey": "UMMADZJLZAPZAW-XOWPVRJPSA-N",
    "display_name": "CARBOPROST TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "aa42587d-7213-4a46-9050-9bbfbb081de5": {
      "match": "brand_token",
      "title": "CARBOPROST TROMETHAMINE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "55150-459_1e7bd8be-a282-4c66-8e1f-bb3ef78c327a",
  "productndc": "55150-459",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216939",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBOPROST TROMETHAMINE",
  "proprietary_name": "CARBOPROST TROMETHAMINE",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA216939",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBOPROST TROMETHAMINE",
  "start_marketing_date": "20230525",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code G02AD.

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